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Sponsors and Collaborators: |
Dartmouth-Hitchcock Medical Center National Cancer Institute (NCI) |
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Information provided by: | Dartmouth-Hitchcock Medical Center |
ClinicalTrials.gov Identifier: | NCT00153816 |
Extensive experimental and observational data suggest that intake of calcium and of vitamin D exert protective effects on colorectal neoplasia. Building on their previous work, the investigators will investigate the chemopreventive effect of vitamin D in the large bowel, to study whether calcium with vitamin D is more effective than calcium alone, and to confirm their positive finding regarding calcium. The goal of this study is the development of chemopreventive combinations that will reduce risk of colorectal neoplasia sufficiently to permit the lengthening of surveillance intervals in most patients and to clarify important issues regarding the mechanisms of colorectal carcinogenesis and chemoprevention.
Condition | Intervention | Phase |
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Colorectal Cancer Polyps Adenomas |
Dietary Supplement: Calcium Carbonate Dietary Supplement: Vitamin D3 Dietary Supplement: placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Vitamin D/Calcium Polyp Prevention Study |
Estimated Enrollment: | 2200 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | December 2017 |
Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
placebo
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Dietary Supplement: placebo
placebo; two tablets per day
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2: Experimental
calcium
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Dietary Supplement: Calcium Carbonate
3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 gm/tablet
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3: Experimental
vitamin D
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Dietary Supplement: Vitamin D3
1000 IU/daily; two tablets per day; 500 IU per tablet
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4: Experimental
calcium plus vitamin D
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Dietary Supplement: Calcium Carbonate
3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 gm/tablet
Dietary Supplement: Vitamin D3
1000 IU/daily; two tablets per day; 500 IU per tablet
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This study is a double-blind, placebo-controlled trial of vitamin D and/or calcium supplementation for the prevention of large bowel adenomas. Subjects will be recruited from 10 Study Centers in North America. Eligible subjects will have had at least one large bowel adenoma removed in the 4 months prior to study entry and no remaining polyps in the bowel after complete colonoscopic examination. Participants will be randomized in a modified 2 x 2 factorial design to vitamin D (1000 IU/day), calcium carbonate (1200 mg elemental calcium/day), both agents, or placebo only. Women who decline to forego calcium supplementation will be randomized only to calcium alone or to calcium plus vitamin D. Randomization will be stratified by gender, study center of recruitment, and anticipated follow-up interval (see below), and will be conducted separately for female subjects randomized only to vitamin D.
We anticipate enrolling about 2500 participants to reach a total of approximately 2000 randomized subjects. As safety measures, blood levels of calcium, creatinine, and 25-(OH)-vitamin D will be obtained at baseline and 1 year after randomization, as well as 3 years after randomization for subjects with a 5-year surveillance cycle. Every six months after randomization subjects will complete a questionnaire regarding compliance with study agents, use of medications and vitamin/mineral supplements, illnesses, hospitalizations, and dietary intake of calcium and vitamin D. The endpoint of the study will be new adenomas detected on follow-up colonoscopy. These examinations are scheduled to occur either 3 years or 5 years after the qualifying examination, depending on the follow-up interval recommended by each patient's endoscopist. Some patients may, for medical reasons, have a colonoscopy at a time other than 3 or 5 years after the qualifying examination. Information from these exams will be included in analyses where appropriate. In the primary analyses, the occurrence of new neoplastic polyps in the interval between randomization and the follow-up exam will be compared between subjects randomized to vitamin D (with or without calcium) versus those randomized to placebo (with or without calcium), between subjects randomized to calcium (with or without vitamin D) versus those randomized to placebo (with or without vitamin D, excluding women electing to receive calcium and therefore cannot participate in the calcium component of the study), and between those randomized to calcium plus vitamin D versus those randomized to calcium alone. In secondary analyses, we will examine the effect of calcium plus vitamin D versus vitamin D alone, and the impact of baseline vitamin D levels and VDR polymorphisms on the vitamin D effects. Effects on advanced adenomas will also be assessed.
Ages Eligible for Study: | 45 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
General exclusionary criteria:
Exclusions due to derangement of calcium metabolism or indications /contraindications to study agents:
Exclusions due to intestinal or bowel problems:
Exclusions due to poor health:
Exclusions due to shipping regulations:
Drug exclusions:
United States, California | |
University of Southern California | |
Los Angeles, California, United States, 90089 | |
United States, Colorado | |
University of Colorado | |
Denver, Colorado, United States, 80220 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Iowa | |
University of Iowa | |
Iowa City, Iowa, United States, 52242 | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, New Hampshire | |
Dartmouth Hitchcock Medical Center | |
Lebanon, New Hampshire, United States, 03766 | |
United States, North Carolina | |
University of North Carolina | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
United States, South Carolina | |
University of South Carolina | |
Columbia, South Carolina, United States, 29203 | |
United States, Texas | |
University of Texas | |
Houston, Texas, United States, 77030 | |
Puerto Rico | |
University of Puerto Rico | |
San Juan, Puerto Rico |
Principal Investigator: | John A. Baron, MD | Dartmouth-Hitchcock Medical Center |
Responsible Party: | Dartmouth Medical School ( John A. Baron, Professor of Medicine and of Community & Family Medicine ) |
Study ID Numbers: | 5 R01 CA098286-03 |
Study First Received: | September 7, 2005 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00153816 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Colorectal neoplasms Adenomatous polyps |
Pathological Conditions, Anatomical Cholecalciferol Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Bone Density Conservation Agents Trace Elements Polyps Calcium Carbonate Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Calcium, Dietary Vitamin D Digestive System Diseases Vitamins Gastrointestinal Neoplasms Antacids Micronutrients Adenoma Colorectal Neoplasms Adenomatous Polyps |
Pathological Conditions, Anatomical Cholecalciferol Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Growth Substances Physiological Effects of Drugs Colonic Diseases Bone Density Conservation Agents Polyps Calcium Carbonate Intestinal Diseases |
Rectal Diseases Pharmacologic Actions Intestinal Neoplasms Neoplasms Vitamin D Neoplasms by Site Digestive System Diseases Vitamins Gastrointestinal Neoplasms Antacids Micronutrients Colorectal Neoplasms |